I was looking forward to learn more about the TGA’s perspective on biosimilars during our TGA visit but unfortunately, the speaker decided not to talk about this topic due to time constraints.
Medicines that contains one or more active substances made by or derived from biological sources are called biological medicines e.g. bacterium, yeast, erythropoietins etc. In simple terms, biosimilars can be thought of as generic versions of biological medicines. They are not considered the same as generics though, since generics have simpler chemical structures and are considered to be identical to their reference medicines. The reference biological medicines should have already been authorised by a regulatory body.
For a company to be able to make a biosimilar medicine, they have to conduct studies to show that the biosimilar medicine is similar to the reference medicine and it does not have any meaningful differences from reference medicine in terms of quality, safety or efficacy; in Australia, the reference medicine must have been authorised for a ‘substantial’ period of time. In Europe, according to the EMA website, this is generally taken to be 10 years.
One basic question I have in mind is – why aren’t biosimilars considered identical to their reference medicines? If it is due to the nature of biological product, then on what basis can we say that it is identical in the same company from one batch to the next/one site of manufacture to the next but biosimilars manufactured by a different manufacturer cannot be considered the same?
- europa.eu. (2016). European Medicines Agency – Q&A: Similar biological products – Biosimilar medicines. [online] Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000318.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac0580281bf0 [Accessed 15 Oct. 2016].
- Anon, (2016). [online] Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2009/12/WC500020062.pdf [Accessed 15 Oct. 2016].
- Therapeutic Goods Administration (TGA). (2016). Regulation of biosimilar medicines. [online] Available at: https://www.tga.gov.au/publication/evaluation-biosimilars [Accessed 16 Oct. 2016].